Today’s Flickr Photo

The U.S. Supreme Court for Sale. Flickr photo by takomabibelot.

If you read one thing today . . .

We already knew that pharma giant GlaxoSmithKline wasn’t above putting profits before patient health. There’s the case of its diabetes drug Avandia, the sale of which the FDA recently restricted. And now comes the disturbing news that the British drug maker knowingly sold contaminated baby ointment and an antidepressant that didn’t work. Glaxo will pay $750 million to settle criminal and civil complaints in this latest round of court cases, write Gardiner Harris and Duff Wilson in the New York Times. The case was sparked by complaints from Glaxo’s former quality manager, Cheryl D. Eckard, who told the FDA about serious problems at Glaxo’s premier manufacturing facility in Puerto Rico:

But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

Overheard:

By now you’ve probably seen the video from the Rand Paul for U.S. Senate campaign rally in Lexington, Ky. where Paul supporters wrestled a female MoveOn.org protestor to the ground and one man stepped on her head. The guy who appears on video to be stomping 23-year-old Lauren Valle has told reporters that he wasn’t trying to hurt her. Rather, he was trying to hold her down for police and had to use his foot because a bad back prevents him from bending over. Valle told police she was assaulted while trying to take a photo with Paul while holding a fake “employee of the month” award:

“I think that this is an extreme example of the kinds of sentiments that people are feeling in many races across the country,” Valle said. “I think that tension is incredibly high.”

By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Tomorrow, our own Sid Wolfe will be testifying before an FDA advisory committee about the much talked about diabetes drug Avandia, manufactured by drug maker GlaxoSmithKline. The New York Times reported today that GlaxoSmithKline hid data indicating Avandia’s adverse effects for 11 years. The New York Times also explained the history of this dangerous drug.

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Excuse our impatience, but we’ve been warning about Avandia for a decade. We petitioned the Food and Drug Administration to ban Avandia (also known as Rosiglitazone) back in 2000. Sid Wolfe has been saying all the things “recently uncovered” for years. It finally looks like something might happen though; the FDA is meeting to discuss Avandia today.

Public Citizen has been concerned about the heart dangers caused by the diebetes drug Avandia for a decade. But to add insult to injury, the makers of the drug are also now involved in an international unethical study involving it. If that weren’t bad enough, this study was ordered by the FDA. What?! Something isn’t right here.

GlaxoSmithKline, Avandia’s manufacturer, pressed forward with the FDA-requested study, drawing a pool of 16,000 subjects from 14 countries. It pits the diabetes drug against its competitor, Actos, even though some FDA officials have called the trial “exploitive of patients.”

“Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage,” Wolfe told the lawmakers.

But FDA Commissioner Margaret Hamburg defended the study, as reported by the AP and picked up by Bloomberg BusinessWeek. Hopefully it won’t take until the end of the study in 2015 for someone to step in and protect these patients, who are suffering from type 2 diabetes without knowing that their so-called treatment could be causing them further harm.